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MINIPRESS SUMMARY

Minipress®Capsules(prazosin hydrochloride)For Oral Use

MINIPRESS® (prazosin hydrochloride), a quinazoline derivative, is the first of a new chemical class of antihypertensives.

MINIPRESS (prazosin hydrochloride) is indicated in the treatment of hypertension. It can be used alone or in combination with other antihypertensive drugs such as diuretics or beta adrenergic blocking agents.

Efficacy of anti-scorpion venom serum over prazosin in the management of severe scorpion envenomation. [2010.10]BACKGROUND: Scorpion venoms cause a massive release of neurotransmitters. Either anti-scorpion venom serum (AScVS) or prazosin has been used in the management of severe scorpion envenomation. AIMS: To compare the time taken for clinical recovery by patients with severe scorpion envenomation after AScVS therapy with that following prazosin therapy. SETTINGS AND DESIGN: A prospective, open-labeled clinical trial was undertaken to compare the effects of the AScVS and/or prazosin on clinical recovery in scorpion-stung patients... CONCLUSIONS: Intravenous slow bolus of AScVS given based on the clinical severity of envenomation leads to early recovery than prazosin alone and is well tolerated.

A pilot trial of the alpha-1 adrenergic antagonist, prazosin, for alcohol dependence. [2009.02]BACKGROUND: Current medications for alcohol dependence (AD) show only modest efficacy. None target brain noradrenergic pathways. Theory and preclinical evidence suggest that noradrenergic circuits may be involved in alcohol reinforcement and relapse. We therefore tested the alpha-1 adrenergic receptor antagonist, prazosin, as a pharmacotherapy for AD... CONCLUSIONS: Prazosin holds promise as a pharmacologic treatment for AD and deserves further evaluation in a larger controlled trial.

Clinical Trials Related to Minipress (Prazosin)

Monoamine Antagonist Therapies for Methamphetamine Abuse Prazosin [Recruiting]
This protocol will test the safety, effectiveness and the metabolism and action of prazosin
as a potential therapy for methamphetamine abuse. This will be accomplished by performing a
series of human laboratory studies. In each of these studies, the safety and effectiveness
of the test medication (prazosin) in the treatment of methamphetamine effects will be
determined. The study hypothesis is that prazosin will block the methamphetamine receptor
function, reducing the reinforcing effects of central nervous system effects in humans.

CSP #563 - Prazosin and Combat Trauma PTSD (PACT) [Recruiting]
Background: Posttraumatic stress disorder (PTSD) is a debilitating and disabling mental
disorder that afflicts at least 25% of veterans who have suffered life-threatening war zone
trauma. Trauma-related nightmares and sleep disturbance are among the most
treatment-resistant PTSD symptoms in veterans. Increased responsiveness to central nervous
system (CNS) norepinephrine (NE) contributes to the pathophysiology of overall PTSD and
treatment-resistant nighttime symptoms. Placebo-controlled pilot studies demonstrate that
the generically available CNS-active alpha-1 adrenoreceptor antagonist prazosin
substantially reduces PTSD trauma nightmares and sleep disturbance and improves global
clinical status (sense of well being and ability to function) in veterans.

Objective: The primary objective is to demonstrate in a large multi-site placebo-controlled
trial in veterans with war zone trauma-induced PTSD that prazosin is efficacious for PTSD
trauma nightmares, sleep disturbance, and global clinical status. A secondary objective is
to demonstrate prazosin effectiveness for these outcome measures during clinically
meaningful long-term (26 week) maintenance treatment of PTSD. We will also address prazosin
efficacy and long-term effectiveness for improving total PTSD symptoms, comorbid depression,
quality of life, and physical functioning.

Methods: This 26 week randomized double-blind placebo-controlled study is designed to
demonstrate both short term efficacy and long term effectiveness of prazosin for PTSD. The
research design encompasses a shorter-term, more tightly controlled efficacy component and a
longer-term, more .real world. effectiveness component. Three hundred twenty-six veterans

with war zone - related PTSD and persistent trauma nightmares will be randomized 1: 1 to

prazosin or placebo. Study drug will be increased using a flexible dose titration schedule
based on clinical response and adverse effects to an optimum maintenance dose (1-20 mg/day).
During the first 10 weeks of the study, participants will be randomized to prazosin or
placebo. Previous psychotropic medications and/or psychotherapy will be maintained constant.
Short term efficacy will be determined during the first 10 weeks. During the remaining 16
weeks of the 26 week trial, subjects will continue to receive stable-dose double-blind
prazosin or placebo, but will have the option to receive additional psychotropic medications
and/or psychotherapeutic interventions, as needed, per the judgment of the study Clinician
Prescriber. It is hypothesized that prazosin will remain more clinically effective than
placebo at the end of the 26-week trial, demonstrating that prazosin adds benefit
over-and-above other treatments that are naturalistically administered by providers in a
.real world. clinical setting.

Prazosin will be judged efficacious at 10 weeks if superior to placebo on all three primary
outcome measures assessing trauma nightmares, sleep disturbance, and global clinical status:
the Recurrent Distressing Dreams item of the Clinician Administered PTSD Scale (CAPS), the
Pittsburgh Sleep Quality Index (PSQI), and the Clinical Global Impression of Change (CGIC).
Secondary outcome measures will assess prazosin effects on total PTSD symptoms, depression,
physical functioning, and quality of life. Adverse effects and cardiovascular measures,
including supine and standing blood pressure (BP) and heart rate (HR) will be assessed.

Efficacy of Sleep Interventions for Posttraumatic Stress Disorder (PTSD) [Recruiting]
The purpose of this research study is to evaluate and compare the effects of experimental
treatments aimed at improving insomnia and nightmares in men and women military veterans
between the ages of 18 and 60 years old, and who have a condition called Posttraumatic
Stress Disorder. Insomnia refers to difficulty falling or staying asleep, although enough
time is allowed for sleeping. Insomnia is also associated with daytime consequences, such as
lack of energy, irritability, and difficulty concentrating. Nightmares are bad dreams that
may or may not awaken the sleeper, and that cause discomfort during the daytime.

Chronic Posttraumatic Stress Disorder (PTSD) refers to symptoms that occur after someone
experienced or witnessed a life-threatening event, and that persist for three months or more
after the event. Symptoms include flashbacks, nightmares, feelings of detachment from
others, sleep disturbances, irritability, anxiety, and efforts to avoid people and places
associated with the life-threatening event. These symptoms occur after a life-threatening
event. Symptoms that persist for more than one month indicate the presence of PTSD. In the
present study, we will study people with chronic PTSD, which refers to PTSD symptoms that
persist for more than 3 months.

Efficacy of a treatment is defined as the capacity to produce the desired effects. In this
study, we will evaluate and compare the capacity of two active experimental treatments to
reduce insomnia and nightmares associated with PTSD, and one inactive intervention, called a
placebo, for people who continue to have sleep difficulties despite receiving treatment with
an antidepressant medication called a selective serotonin reuptake inhibitor (SSRI, like
Prozac, Paxil, Zoloft, Celexa). The two active experimental treatments are a medication,
prazosin, and a brief behavioral intervention, which involves exercises and techniques to
reduce nightmares and improve sleep quality. Prazosin is an approved medication by the Food
and Drug Administration (FDA) against high blood pressure, but is not FDA-approved for
posttraumatic insomnia and nightmares.